Evaluating Additional Platelet Inhibition in Patients With High Platelet Reactivity Undergoing Percutaneous Coronary Intervention

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. The investigators know some patients do not respond fully to Clopidogrel but currently patients are not tested for this.

The investigators wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.

Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity.

1. Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive.

2. High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30±5 days is required to assess how patients are doing, medications and occurrence of any events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborator: University Hospital Tuebingen
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

1. ACS patients with intent for PCI <72 hours from admission.

2. Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel

3. High platelet reactivity (HPR) PA > 400 AU min by multiplate analyser ("poor responders")

4. Initial platelet function sample at least 2 hours after pre PCI loading dose

5. Consent

Exclusion Criteria:

1. Patients <18 years and >75 years

2. Body weight <60kg

3. Pretreatment with prasugrel within 7 days of randomisation

4. History of stroke or transient ischaemic attack

5. Patients with increased bleeding risk e.g.

• recent major trauma or surgery

• gastrointestinal bleeding or active peptic ulceration

• Platelet count <100,000 / mm3 at the time of screening

• Internationally Normalized Ratio (INR)> 1.5 at the time of screening

6. Hb<10g/dL

7. Intracranial neoplasm, arteriovenous malformation or aneurysm.

8. Severe hepatic impairment (Child Pugh class C)

9. Intention to use the following medications

• oral anticoagulation

• other antiplatelet therapy (including GPIIb/IIIa inhibitors) besides aspirin

• nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors

10. Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding

11. Known allergy, hypersensitivity or other contraindications to prasugrel or clopidogrel